Matthias Kindler and Niels Hölder of Hoffmann-Eitle (Munich) then took a look at German SPC cases in 2008: they delved into the seemingly unending topic of determining what a first authorization is, especially when the first authorization is one in an EEA member state (the EEA was founded after Regulation 1768/92 entered into force, and the Regulation came into force before, SE, FI and AT acceeded to the EC). This issue was decided by the German Federal Supreme Court (FSC) in the "Pantoprazol" case (X ZB 31/06, 27 May 2008). They also tackled the combination issue ("Anti-helicobacter preparation", FSC X ZB1/08, 8 July 2008) and the problem of having different salts as different active ingredients (FSC X ZB 4/08, 14 October 2008). They then reported on the decision of the German Patent Court to refuse the grant of an SPC with a negative term. This decision has been appealed.
The afternoon's PowerPoint presentations should be available soon. Currently The SPC Blog has versions that can neither be copied nor legibly uploaded. Please be patient!We also have a question, which readers are invited to answer. Lisa Page asks:
"In Dr Cullen's presentation he mentioned the possibility that an applicant could benefit from both an six month extension to an SPC under the paediatric regulation and a one year extension to a marketing authorisation for a new clinical indication? In what circumstances can the SPC Blog readers see that this would be a practical benefit to an applicant bearing in mind that they could have selected a one year extension to marketing authorisation under the paediatric regulation in the first instance?"If you have any bright ideas, please post them as Comments below or email them here